The successful candidate is responsible for acting as the regulatory representative on developmental core teams culminating in the preparation of relevant regulatory filings to FDA.
•Participation on product design teams
•Creates evaluates and updates Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
•Reviews labeling/promotional/advertising materials, and other documents to ensure compliance
•Maintains current knowledge of relevant regulations, including proposed and final rules.
•Interprets RA policies and guidance and correctly apply them as regulatory activities